The regulatory affairs and clinical trials administration core will provide all resources necessary for the collation and submission of the IND to the Food and Drug Administration and project management of the Pre- Clinical studies and Phase 1 clinical trials of the human monoclonal anti- cocaine antibody. The University of Cincinnati's existing Clinical Trials program the direction of the Core A project leader has provided all the necessary administrative support for the initiation and conduct of clinical drug trials on novel psychotropic agents for the treatment of psychiatric disorders including substance abuse. Over the past five years, the program has conducted (or is currently conducting) over 100 clinical trials involving psychotropic agents for numerous psychiatric and substance abuse indications, and has also developed excellent working relationships with local and national regulatory agencies, and with many pharmaceutical companies. These trials have included pharmacokinetic, pharmacodynamic, safety and efficacy and abuse potential studies, ranging from phase I through phase IV in both normal volunteer and patient populations. This core unit will serves as the central regulatory liaison between the University of Cincinnati-based SPIRCAP projects and core facilities and GenPharm, Medarex, the NIDA-designated toxicology laboratory, the University of Cincinnati IRB and the pre and post IND meetings with the FDA divisions of CBER and CDER. This core will establish a comprehensive project plan to provide the investigators with the guidelines for achieving regulatory requirements. It will assemble all pre-clinical pharmacological and toxicological results performed during year 1 and 2 of the project, identify rate-limiting steps and work with each of the sections in order to efficiently complete the requirements for filing the IND. In addition to the regulatory administration, Core A will be responsible for coordinating protocol development, and the conduct, data management and analysis of the pre-clinical and Phase I studies. Three Phase I studies have been designed and will be implemented in years 3 and 4 of the project. These include: Double-blind, placebo-controlled (1) acute single dose and (2) repeated dose pharmacokinetic studies, to evaluate the safety of the antibody in normal subjects (Project 3). (3) A double-blind cocaine infusion study evaluating the subjective and cardiovascular effects of the combination of the antibody and cocaine in cocaine-dependent subjects (Project 4). Core A will initiate, coordinate monitor and manage all clinical trials proposed in this application according to Good Clinical Practice standards.
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